【摘要】 目的 研究影响马来酸依那普利片在加速稳定性试验中有关物质含量不稳定的主要因素，并对工艺处方进行优化。方法 应用加速实验法，以有关物质含量为考察指标，对处方中各辅料及生产工艺进行考察。结果 马来酸依那普利片生产处方中辅料氢氧化铝、硬脂酸镁以及≤70℃条件下3～4h的干燥工艺对有关物质含量有很大的影响。以马来酸依那普利原料、乳糖、微晶纤维素、预胶化淀粉、微粉硅胶、滑石粉为处方组成，10%PVP乙醇(75%)溶液作粘合剂，按≤40℃条件下1～2h的干燥工艺生产的马来酸依那普利片其有关物质具有良好的稳定性。结论 生产处方中有碱性物质的存在及较高温度下长时间干燥的生产工艺是马来酸依那普利片在加速稳定性试验中有关物质含量不稳定的主要因素。

    【关键词】 马来酸依那普利； 有关物质； 加速试验

    【Abstract】 Objective To research the main factor which influence related substance content of enalapril maleate in accelerating the stability test, and optimize the craft prescription.Methods Use the accelerate test regard content of related substances as the index of investigating,investigate all auxiliary materials and production technology in the prescription.Results In the enalapril maleate produce prescription,the auxiliary materials aluminium hydroxide,stearate and the dry crafts of 3～4 hours under the condition of ≤70 degerees centigrade have great influence on content of related substances . With enalapril maleate, lactose, microcrystalline cellulose, pregelatinized starch, aerosil, talc makes up for the prescription, 10% of the PVP ethanol(75%) solution act as the binder, according to the dry crafts of dry 1～2 hours under the condition of ≤40 degrees centigrade produce the enalapril maleate which content of related substances have good stability.Conclusion There are alkaline material in produce prescription and long–time dry production technology of high temperature that is the main factor which influence the content of related substances in the enalapril maleate while testing. ......